Description:
This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability,
pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate
safety and anti- tumor activity of Q702 administered orally.
Title
- Brief Title: Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor
- Official Title: A Phase 1, Multicenter, Open-label, Dose- Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 With a Cohort Expansion at the RP2D in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
Q702-ONC-P1-US001
- NCT ID:
NCT04648254
Conditions
- Solid Tumor
- Advanced Cancer
- Metastatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
Q702 | | Dose escalation (Q702) |
Purpose
This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability,
pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate
safety and anti- tumor activity of Q702 administered orally.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose escalation (Q702) | Experimental | Participants will receive escalating doses of Q702 | |
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically or cytologically confirmed advanced or metastatic solid
tumors, that have progressed following standard of care therapy or for which there is
no standard therapy which confers clinical benefit
- Measurable disease per RECIST v 1.1
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Age ≥ 18 years
- Signed, written IRB-approved informed consent form
Exclusion Criteria:
- New York Heart Association Class III or IV cardiac disease, or myocardial infarction,
severe unstable angina, coronary/peripheral artery bypass graft, congestive heart
failure within the past 6 months
- Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470
msec (females) and >450 msec (males)
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy
- Active, poorly controlled autoimmune or inflammatory diseases
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702 |
Time Frame: | 28 days of cycle 1 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Change in the area under curve (AUC) of Q702 |
Time Frame: | Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22 |
Safety Issue: | |
Description: | |
Measure: | Change in the maximum plasma concentration (Cmax) of Q702 |
Time Frame: | Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22 |
Safety Issue: | |
Description: | |
Measure: | Change in the time of maximum plasma concentration (Tmax) of Q702 |
Time Frame: | Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22 |
Safety Issue: | |
Description: | |
Measure: | Tumor response using RECIST version 1.1 throughout study |
Time Frame: | Baseline up to approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Qurient Co., Ltd. |
Last Updated
July 30, 2021